Cervical Cancer Vaccine Gardacil Recommended for Approval by FDA

In a unanimous vote, an FDA advisory committee recently voted to endorse the safety and effectiveness of Gardasil. The new vaccine developed by Merck Pharmaceuticals has been shown to protect women from two types of the human papilloma virus, responsible for about 70% of cervical cancer cases. The potential to cut worldwide deaths from the disease is huge.


HPV is the most common sexually transmitted disease, affecting an estimated 50% of sexually active adults. Each year, cervical cancer kills 290,000 women worldwide. About 3,500 of the annual deaths occur in the U.S., where many women have the opportunity for early detection through regular pap smears. Treatment for precancerous lesions and early cervical cancer greatly reduce mortality rates in the U.S..

Gardasil is the first vaccine known to prevent cervical cancer. If approved by the FDA, the Merck vaccine could be the biggest advance in eradicating cervical cancer since the pap test was introduced decades ago.

Merck recommends using the vaccine in females age 9 to 26. Gardasil can be most effective if young girls are vaccinated before they became sexually active. The vaccine is not intended to take the place of regular cervical screening.

The FDA is expected to endorse the use of the vaccine at a June meeting. If approval is given, a national Advisory Committee on Immunization Practices will decide whether to advocate routine vaccination with Gardasil.

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